A Phase Ib/II Clinical Study on AK112 Combined or Not Combined With AK119 in pMMR/MSS Colorectal Cancer

Sponsor
Akeso
Study ID
NCT05846867
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AK119 — DRUG
    AK119 IV every 2 weeks.intravenous infusion
  • AK112 — DRUG
    AK112 IV every 2 weeks.intravenous infusion
  • Oxaliplatin — DRUG
    Oxaliplatin: 85mg/m2, intravenous infusion
  • Irinotecan — DRUG
    Irinotecan 180mg/m2, intravenous infusion
  • Calcium folinate — DRUG
    Calcium folinate: 400mg/m2, intravenous infusion
  • Fluorouracil — DRUG
    Fluorouracil 400mg/m2, intravenous injection

Study Details

This is an open label, multicenter Phase Ib/II clinical study on the efficacy and safety of AK119 and AK112 in combination with or without chemotherapy, and AK112 monotherapy in pMMR/MSS CRC

Key Dates

First listed
May 6, 2023
Start date
May 8, 2023
Status verified
Mar 2026
Primary completion
May 8, 2026
Completion
Aug 11, 2026

Study Design

Enrollment
170 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: AK119 20mg/kg+ AK112 20mg/kg
    Subjects will receive AK119 plus AK112 via intravenously (IV) Q2W, up to 2 years
  • Experimental: AK119 40mg/kg+ AK112 20mg/kg
    Subjects will receive AK119 plus AK112 via intravenously (IV) Q2W, up to 2 years
  • Experimental: AK119 + AK112 20mg/kg +mFOLFOX6
    Subjects will receive AK119 and AK112 plus mFOLFOX6 via intravenously (IV)Q2W, up to 12 cycles. Afterward, AK119 and AK112 will continue to be treated up to 2 years.
  • Experimental: AK119 + AK112 20mg/kg +FOLFIRI
    Subjects will receive AK119 and AK112 plus FOLFIRI via intravenously (IV)Q2W, up to 12 cycles. Afterward, AK119 and AK112 will continue to be treated up to 2 years.
  • Experimental: AK112 20mg/kg
    Subjects will receive AK112 via intravenously (IV) Q2W, up to 2 years

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: Up to 2 years ]

Find similar trials

Nationwide
Colorectal cancer trialsOncology trialsGI oncology trials

Related Studies